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Guideline issued for treating Tourette syndrome and chronic tics
PHILADELPHIA – Approaches to managing tics in patients with Tourette syndrome or chronic tic disorders “should be individualized, and the choice should be the result of a collaborative decision among patient, caregiver, and clinician, during which the benefits and harms of individual treatments as well as the presence of comorbid disorders are considered,” according to Tamara Pringsheim, MD, lead author of a practice guideline published May 6, 2019, by the American Academy of Neurology, and her collaborators.
The panel of nine physicians, two psychologists, and two patient representatives developed the recommendations based on a comprehensive systematic literature review. They concluded that treatments may decrease the frequency and severity of tics but rarely eliminate them.
The guideline was endorsed by the Child Neurology Society and the European Academy of Neurology and is the first such guideline for American neurologists, said Dr. Pringsheim of the University of Calgary (Alta.). Like recent Canadian and European guidelines, it strongly supports the Comprehensive Behavioral Intervention for Tics (CBIT) as a treatment option for tics.
After examining which medical, behavioral, and neurostimulation interventions, compared with placebo or other active interventions, improve tic severity and tic-related impairment in children and adults with Tourette syndrome or a chronic tic disorder, the guideline writers recommended that the evidence was strongest for CBIT as a first-line treatment, relative to other behavioral treatments and medications.
If symptoms affect a patient’s daily life, doctors should consider CBIT, said guideline author John Piacentini, PhD, of the University of California, Los Angeles, at the annual meeting of the American Academy of Neurology. “This treatment combines habit-reversal training, which teaches patients how to control their urges to tic, with other behavioral strategies to reduce stress and other factors that often make tics worse.”
Patients typically see results from CBIT in 8-12 weeks. More CBIT providers are needed, however, to make the treatment readily available to all patients, he said.
The guideline panel members said that there was moderate confidence in the evidence for reduced tic severity for the following therapeutic approaches, compared with placebo: haloperidol, risperidone, aripiprazole (children only), tiapride (children only), clonidine, onabotulinumtoxinA injections, ningdong granule (as formulated by Zhao), (children only), and ling granule (children only). There was low or very low confidence in the evidence for all other therapies for reducing tic severity.
Comorbid conditions
Many people with tic disorders have neurodevelopmental or psychiatric conditions such as ADHD, obsessive-compulsive disorder, and mood and anxiety disorders. The guideline recommends that people with tics be evaluated for these conditions.
Alpha2-adrenergic agonists may improve symptoms of tic disorders and ADHD, the authors said. There was moderate confidence in the evidence for reduced tic severity for people with a comorbid diagnosis of ADHD with clonidine plus methylphenidate (children only) and methylphenidate alone (children only), compared with placebo.
Adults with severe Tourette syndrome who are resistant to medical and behavioral therapy may benefit from deep brain stimulation (DBS), the guideline states. There was moderate confidence in the evidence for reduced tic severity for DBS of the globus pallidus, compared with sham DBS, as an option for adults with severe tics who have failed CBIT and drugs. These patients first must be screened by a mental health professional and continue to be monitored throughout DBS treatment.
Adults with Tourette syndrome who self-treat their tics with cannabis in states where cannabis is legal should see a doctor who can monitor the use of cannabis for efficacy and adverse effects, the guideline says.
Adverse effects of therapy
The panel also examined the risks of harm, including weight gain, elevated prolactin levels, sedation, drug-induced movement disorders, hypotension, bradycardia, and ECG changes with medical treatments, compared with placebo or other active interventions. In regard to weight gain, the panel concluded with moderate confidence that people with tics receiving risperidone or aripiprazole (children only) are probably more likely to gain weight than people receiving placebo. There was low confidence for associations between specific therapies and elevated prolactin levels.
Compared with people receiving placebo, there was moderate confidence that tiapride is probably associated with higher rates of physical tiredness and sleep disturbances (children only), that clonidine is probably associated with sedation, and that guanfacine is probably associated with drowsiness (children only). There was moderate evidence that pimozide is probably associated with extrapyramidal symptoms. There was low confidence that any specific treatment led to hypotension, bradycardia, or ECG changes.
Additional guideline specifics
The guideline’s practice recommendations include explaining the natural history of tic disorders to patients and caregivers and evaluating patients for functional impairment. Watchful waiting is an acceptable approach in people who do not experience functional impairment, and patients receiving medications for tics must have periodic reevaluations for the need for ongoing medical treatment. People with Tourette syndrome should be referred to resources for psychoeducation for teachers and peers, such as the Tourette Association of America.
Comorbid ADHD occurs in 30%-50% of patients with tics. If screening for ADHD is positive, the burden of ADHD symptoms should be assessed and those with functionally impairing ADHD should be treated for the disorder. Similarly, obsessive-compulsive behaviors occur in 10%-50% of those with Tourette syndrome. If an assessment finds comorbid obsessive-compulsive disorder, it should be treated.
Other psychiatric comorbidities with Tourette syndrome include anxiety disorders, oppositional defiant disorder, and mood disorders. When screening for these conditions, one must inquire about suicidal thoughts and suicide attempts and refer to appropriate resources if present, according to the guidelines.
Individuals with tics and comorbid ADHD should be advised that alpha2-adrenergic agonists may provide benefit for both conditions. Alpha2-adrenergic agonists should be prescribed for the treatment of tics when the benefits of treatment outweigh the risks and patients must be counseled regarding common side effects of alpha2-adrenergic agonists, including sedation. Heart rate and blood pressure must be monitored in patients with tics treated with alpha2-adrenergic agonists. If prescribing extended-release guanfacine, one must monitor the QTc interval in patients with a history of cardiac conditions, patients taking other QT-prolonging agents, or patients with a family history of long QT syndrome. If discontinuing alpha2-adrenergic agonists, they must gradually be tapered to avoid rebound hypertension.
If considering antipsychotic therapies, patients must be counseled on the relative risk for extrapyramidal, hormonal, and metabolic adverse effects to inform decision making on which antipsychotic should be prescribed. Before prescribing antipsychotics for tics, ECGs must be performed. The QTc interval must be measured before and after starting pimozide or ziprasidone, or if antipsychotics are coadministered with other drugs that can prolong the QT interval. The lowest effective dose should be prescribed to decrease the risk of adverse effects, and patients should be monitored for drug-induced movement disorders and for metabolic and hormonal adverse effects of antipsychotics. When attempting to discontinue antipsychotics for tics, the medications should be gradually tapered over weeks to months to avoid withdrawal dyskinesias.
If topiramate is prescribed, patients must be counseled regarding common adverse effects, including cognitive and language problems, somnolence, weight loss, and an increased risk of renal stones.
Some patients with Tourette syndrome use cannabis as a self-medication for tics and comorbidities. Because of the risks associated with cannabis use and widespread self-medication with cannabis for tics, where regional legislation and resources allow, physicians must offer to direct patients to appropriate medical supervision when cannabis is used as self-medication for tics. Appropriate medical supervision would entail education and monitoring for efficacy and adverse effects, according to the guidelines.
Where regional legislation allows, physicians prescribing cannabis-based medication must prescribe the lowest effective dose to decrease the risk of adverse effects. Physicians prescribing cannabis-based medication must inform patients that medication may impair driving ability. Physicians prescribing cannabis-based medication to patients with Tourette syndrome must periodically reevaluate the need for ongoing treatment.
A multidisciplinary evaluation is needed to establish when the benefits of treatment outweigh the risks for prescribing DBS for medication-resistant motor and phonic tics. The DSM-5 diagnosis of Tourette syndrome must be confirmed and exclude secondary and functional tic-like movements when considering DBS for medication-resistant tics. A mental health professional must screen patients preoperatively and follow patients postoperatively for psychiatric disorders that may impede the long-term success of the therapy. Physicians must confirm that multiple classes of medication (antipsychotics, dopamine depleters, alpha1 agonists) and behavioral therapy have been administered (or are contraindicated) before prescribing DBS for tics.
The practice guideline was developed with financial support from AAN. Dr. Pringsheim reported no disclosures. Dr. Piacentini reported receiving funding for travel and speaking from foundations and universities and has received royalties from publishers. In addition, he has performed behavior therapy for tics for approximately 50% of his clinical time and has received financial or material support from Pfizer, the National Institute of Mental Health, and foundations.
SOURCE: Pringsheim T et al. Neurology. 2019 May 6. doi: 10.1212/WNL.0000000000007466.
PHILADELPHIA – Approaches to managing tics in patients with Tourette syndrome or chronic tic disorders “should be individualized, and the choice should be the result of a collaborative decision among patient, caregiver, and clinician, during which the benefits and harms of individual treatments as well as the presence of comorbid disorders are considered,” according to Tamara Pringsheim, MD, lead author of a practice guideline published May 6, 2019, by the American Academy of Neurology, and her collaborators.
The panel of nine physicians, two psychologists, and two patient representatives developed the recommendations based on a comprehensive systematic literature review. They concluded that treatments may decrease the frequency and severity of tics but rarely eliminate them.
The guideline was endorsed by the Child Neurology Society and the European Academy of Neurology and is the first such guideline for American neurologists, said Dr. Pringsheim of the University of Calgary (Alta.). Like recent Canadian and European guidelines, it strongly supports the Comprehensive Behavioral Intervention for Tics (CBIT) as a treatment option for tics.
After examining which medical, behavioral, and neurostimulation interventions, compared with placebo or other active interventions, improve tic severity and tic-related impairment in children and adults with Tourette syndrome or a chronic tic disorder, the guideline writers recommended that the evidence was strongest for CBIT as a first-line treatment, relative to other behavioral treatments and medications.
If symptoms affect a patient’s daily life, doctors should consider CBIT, said guideline author John Piacentini, PhD, of the University of California, Los Angeles, at the annual meeting of the American Academy of Neurology. “This treatment combines habit-reversal training, which teaches patients how to control their urges to tic, with other behavioral strategies to reduce stress and other factors that often make tics worse.”
Patients typically see results from CBIT in 8-12 weeks. More CBIT providers are needed, however, to make the treatment readily available to all patients, he said.
The guideline panel members said that there was moderate confidence in the evidence for reduced tic severity for the following therapeutic approaches, compared with placebo: haloperidol, risperidone, aripiprazole (children only), tiapride (children only), clonidine, onabotulinumtoxinA injections, ningdong granule (as formulated by Zhao), (children only), and ling granule (children only). There was low or very low confidence in the evidence for all other therapies for reducing tic severity.
Comorbid conditions
Many people with tic disorders have neurodevelopmental or psychiatric conditions such as ADHD, obsessive-compulsive disorder, and mood and anxiety disorders. The guideline recommends that people with tics be evaluated for these conditions.
Alpha2-adrenergic agonists may improve symptoms of tic disorders and ADHD, the authors said. There was moderate confidence in the evidence for reduced tic severity for people with a comorbid diagnosis of ADHD with clonidine plus methylphenidate (children only) and methylphenidate alone (children only), compared with placebo.
Adults with severe Tourette syndrome who are resistant to medical and behavioral therapy may benefit from deep brain stimulation (DBS), the guideline states. There was moderate confidence in the evidence for reduced tic severity for DBS of the globus pallidus, compared with sham DBS, as an option for adults with severe tics who have failed CBIT and drugs. These patients first must be screened by a mental health professional and continue to be monitored throughout DBS treatment.
Adults with Tourette syndrome who self-treat their tics with cannabis in states where cannabis is legal should see a doctor who can monitor the use of cannabis for efficacy and adverse effects, the guideline says.
Adverse effects of therapy
The panel also examined the risks of harm, including weight gain, elevated prolactin levels, sedation, drug-induced movement disorders, hypotension, bradycardia, and ECG changes with medical treatments, compared with placebo or other active interventions. In regard to weight gain, the panel concluded with moderate confidence that people with tics receiving risperidone or aripiprazole (children only) are probably more likely to gain weight than people receiving placebo. There was low confidence for associations between specific therapies and elevated prolactin levels.
Compared with people receiving placebo, there was moderate confidence that tiapride is probably associated with higher rates of physical tiredness and sleep disturbances (children only), that clonidine is probably associated with sedation, and that guanfacine is probably associated with drowsiness (children only). There was moderate evidence that pimozide is probably associated with extrapyramidal symptoms. There was low confidence that any specific treatment led to hypotension, bradycardia, or ECG changes.
Additional guideline specifics
The guideline’s practice recommendations include explaining the natural history of tic disorders to patients and caregivers and evaluating patients for functional impairment. Watchful waiting is an acceptable approach in people who do not experience functional impairment, and patients receiving medications for tics must have periodic reevaluations for the need for ongoing medical treatment. People with Tourette syndrome should be referred to resources for psychoeducation for teachers and peers, such as the Tourette Association of America.
Comorbid ADHD occurs in 30%-50% of patients with tics. If screening for ADHD is positive, the burden of ADHD symptoms should be assessed and those with functionally impairing ADHD should be treated for the disorder. Similarly, obsessive-compulsive behaviors occur in 10%-50% of those with Tourette syndrome. If an assessment finds comorbid obsessive-compulsive disorder, it should be treated.
Other psychiatric comorbidities with Tourette syndrome include anxiety disorders, oppositional defiant disorder, and mood disorders. When screening for these conditions, one must inquire about suicidal thoughts and suicide attempts and refer to appropriate resources if present, according to the guidelines.
Individuals with tics and comorbid ADHD should be advised that alpha2-adrenergic agonists may provide benefit for both conditions. Alpha2-adrenergic agonists should be prescribed for the treatment of tics when the benefits of treatment outweigh the risks and patients must be counseled regarding common side effects of alpha2-adrenergic agonists, including sedation. Heart rate and blood pressure must be monitored in patients with tics treated with alpha2-adrenergic agonists. If prescribing extended-release guanfacine, one must monitor the QTc interval in patients with a history of cardiac conditions, patients taking other QT-prolonging agents, or patients with a family history of long QT syndrome. If discontinuing alpha2-adrenergic agonists, they must gradually be tapered to avoid rebound hypertension.
If considering antipsychotic therapies, patients must be counseled on the relative risk for extrapyramidal, hormonal, and metabolic adverse effects to inform decision making on which antipsychotic should be prescribed. Before prescribing antipsychotics for tics, ECGs must be performed. The QTc interval must be measured before and after starting pimozide or ziprasidone, or if antipsychotics are coadministered with other drugs that can prolong the QT interval. The lowest effective dose should be prescribed to decrease the risk of adverse effects, and patients should be monitored for drug-induced movement disorders and for metabolic and hormonal adverse effects of antipsychotics. When attempting to discontinue antipsychotics for tics, the medications should be gradually tapered over weeks to months to avoid withdrawal dyskinesias.
If topiramate is prescribed, patients must be counseled regarding common adverse effects, including cognitive and language problems, somnolence, weight loss, and an increased risk of renal stones.
Some patients with Tourette syndrome use cannabis as a self-medication for tics and comorbidities. Because of the risks associated with cannabis use and widespread self-medication with cannabis for tics, where regional legislation and resources allow, physicians must offer to direct patients to appropriate medical supervision when cannabis is used as self-medication for tics. Appropriate medical supervision would entail education and monitoring for efficacy and adverse effects, according to the guidelines.
Where regional legislation allows, physicians prescribing cannabis-based medication must prescribe the lowest effective dose to decrease the risk of adverse effects. Physicians prescribing cannabis-based medication must inform patients that medication may impair driving ability. Physicians prescribing cannabis-based medication to patients with Tourette syndrome must periodically reevaluate the need for ongoing treatment.
A multidisciplinary evaluation is needed to establish when the benefits of treatment outweigh the risks for prescribing DBS for medication-resistant motor and phonic tics. The DSM-5 diagnosis of Tourette syndrome must be confirmed and exclude secondary and functional tic-like movements when considering DBS for medication-resistant tics. A mental health professional must screen patients preoperatively and follow patients postoperatively for psychiatric disorders that may impede the long-term success of the therapy. Physicians must confirm that multiple classes of medication (antipsychotics, dopamine depleters, alpha1 agonists) and behavioral therapy have been administered (or are contraindicated) before prescribing DBS for tics.
The practice guideline was developed with financial support from AAN. Dr. Pringsheim reported no disclosures. Dr. Piacentini reported receiving funding for travel and speaking from foundations and universities and has received royalties from publishers. In addition, he has performed behavior therapy for tics for approximately 50% of his clinical time and has received financial or material support from Pfizer, the National Institute of Mental Health, and foundations.
SOURCE: Pringsheim T et al. Neurology. 2019 May 6. doi: 10.1212/WNL.0000000000007466.
PHILADELPHIA – Approaches to managing tics in patients with Tourette syndrome or chronic tic disorders “should be individualized, and the choice should be the result of a collaborative decision among patient, caregiver, and clinician, during which the benefits and harms of individual treatments as well as the presence of comorbid disorders are considered,” according to Tamara Pringsheim, MD, lead author of a practice guideline published May 6, 2019, by the American Academy of Neurology, and her collaborators.
The panel of nine physicians, two psychologists, and two patient representatives developed the recommendations based on a comprehensive systematic literature review. They concluded that treatments may decrease the frequency and severity of tics but rarely eliminate them.
The guideline was endorsed by the Child Neurology Society and the European Academy of Neurology and is the first such guideline for American neurologists, said Dr. Pringsheim of the University of Calgary (Alta.). Like recent Canadian and European guidelines, it strongly supports the Comprehensive Behavioral Intervention for Tics (CBIT) as a treatment option for tics.
After examining which medical, behavioral, and neurostimulation interventions, compared with placebo or other active interventions, improve tic severity and tic-related impairment in children and adults with Tourette syndrome or a chronic tic disorder, the guideline writers recommended that the evidence was strongest for CBIT as a first-line treatment, relative to other behavioral treatments and medications.
If symptoms affect a patient’s daily life, doctors should consider CBIT, said guideline author John Piacentini, PhD, of the University of California, Los Angeles, at the annual meeting of the American Academy of Neurology. “This treatment combines habit-reversal training, which teaches patients how to control their urges to tic, with other behavioral strategies to reduce stress and other factors that often make tics worse.”
Patients typically see results from CBIT in 8-12 weeks. More CBIT providers are needed, however, to make the treatment readily available to all patients, he said.
The guideline panel members said that there was moderate confidence in the evidence for reduced tic severity for the following therapeutic approaches, compared with placebo: haloperidol, risperidone, aripiprazole (children only), tiapride (children only), clonidine, onabotulinumtoxinA injections, ningdong granule (as formulated by Zhao), (children only), and ling granule (children only). There was low or very low confidence in the evidence for all other therapies for reducing tic severity.
Comorbid conditions
Many people with tic disorders have neurodevelopmental or psychiatric conditions such as ADHD, obsessive-compulsive disorder, and mood and anxiety disorders. The guideline recommends that people with tics be evaluated for these conditions.
Alpha2-adrenergic agonists may improve symptoms of tic disorders and ADHD, the authors said. There was moderate confidence in the evidence for reduced tic severity for people with a comorbid diagnosis of ADHD with clonidine plus methylphenidate (children only) and methylphenidate alone (children only), compared with placebo.
Adults with severe Tourette syndrome who are resistant to medical and behavioral therapy may benefit from deep brain stimulation (DBS), the guideline states. There was moderate confidence in the evidence for reduced tic severity for DBS of the globus pallidus, compared with sham DBS, as an option for adults with severe tics who have failed CBIT and drugs. These patients first must be screened by a mental health professional and continue to be monitored throughout DBS treatment.
Adults with Tourette syndrome who self-treat their tics with cannabis in states where cannabis is legal should see a doctor who can monitor the use of cannabis for efficacy and adverse effects, the guideline says.
Adverse effects of therapy
The panel also examined the risks of harm, including weight gain, elevated prolactin levels, sedation, drug-induced movement disorders, hypotension, bradycardia, and ECG changes with medical treatments, compared with placebo or other active interventions. In regard to weight gain, the panel concluded with moderate confidence that people with tics receiving risperidone or aripiprazole (children only) are probably more likely to gain weight than people receiving placebo. There was low confidence for associations between specific therapies and elevated prolactin levels.
Compared with people receiving placebo, there was moderate confidence that tiapride is probably associated with higher rates of physical tiredness and sleep disturbances (children only), that clonidine is probably associated with sedation, and that guanfacine is probably associated with drowsiness (children only). There was moderate evidence that pimozide is probably associated with extrapyramidal symptoms. There was low confidence that any specific treatment led to hypotension, bradycardia, or ECG changes.
Additional guideline specifics
The guideline’s practice recommendations include explaining the natural history of tic disorders to patients and caregivers and evaluating patients for functional impairment. Watchful waiting is an acceptable approach in people who do not experience functional impairment, and patients receiving medications for tics must have periodic reevaluations for the need for ongoing medical treatment. People with Tourette syndrome should be referred to resources for psychoeducation for teachers and peers, such as the Tourette Association of America.
Comorbid ADHD occurs in 30%-50% of patients with tics. If screening for ADHD is positive, the burden of ADHD symptoms should be assessed and those with functionally impairing ADHD should be treated for the disorder. Similarly, obsessive-compulsive behaviors occur in 10%-50% of those with Tourette syndrome. If an assessment finds comorbid obsessive-compulsive disorder, it should be treated.
Other psychiatric comorbidities with Tourette syndrome include anxiety disorders, oppositional defiant disorder, and mood disorders. When screening for these conditions, one must inquire about suicidal thoughts and suicide attempts and refer to appropriate resources if present, according to the guidelines.
Individuals with tics and comorbid ADHD should be advised that alpha2-adrenergic agonists may provide benefit for both conditions. Alpha2-adrenergic agonists should be prescribed for the treatment of tics when the benefits of treatment outweigh the risks and patients must be counseled regarding common side effects of alpha2-adrenergic agonists, including sedation. Heart rate and blood pressure must be monitored in patients with tics treated with alpha2-adrenergic agonists. If prescribing extended-release guanfacine, one must monitor the QTc interval in patients with a history of cardiac conditions, patients taking other QT-prolonging agents, or patients with a family history of long QT syndrome. If discontinuing alpha2-adrenergic agonists, they must gradually be tapered to avoid rebound hypertension.
If considering antipsychotic therapies, patients must be counseled on the relative risk for extrapyramidal, hormonal, and metabolic adverse effects to inform decision making on which antipsychotic should be prescribed. Before prescribing antipsychotics for tics, ECGs must be performed. The QTc interval must be measured before and after starting pimozide or ziprasidone, or if antipsychotics are coadministered with other drugs that can prolong the QT interval. The lowest effective dose should be prescribed to decrease the risk of adverse effects, and patients should be monitored for drug-induced movement disorders and for metabolic and hormonal adverse effects of antipsychotics. When attempting to discontinue antipsychotics for tics, the medications should be gradually tapered over weeks to months to avoid withdrawal dyskinesias.
If topiramate is prescribed, patients must be counseled regarding common adverse effects, including cognitive and language problems, somnolence, weight loss, and an increased risk of renal stones.
Some patients with Tourette syndrome use cannabis as a self-medication for tics and comorbidities. Because of the risks associated with cannabis use and widespread self-medication with cannabis for tics, where regional legislation and resources allow, physicians must offer to direct patients to appropriate medical supervision when cannabis is used as self-medication for tics. Appropriate medical supervision would entail education and monitoring for efficacy and adverse effects, according to the guidelines.
Where regional legislation allows, physicians prescribing cannabis-based medication must prescribe the lowest effective dose to decrease the risk of adverse effects. Physicians prescribing cannabis-based medication must inform patients that medication may impair driving ability. Physicians prescribing cannabis-based medication to patients with Tourette syndrome must periodically reevaluate the need for ongoing treatment.
A multidisciplinary evaluation is needed to establish when the benefits of treatment outweigh the risks for prescribing DBS for medication-resistant motor and phonic tics. The DSM-5 diagnosis of Tourette syndrome must be confirmed and exclude secondary and functional tic-like movements when considering DBS for medication-resistant tics. A mental health professional must screen patients preoperatively and follow patients postoperatively for psychiatric disorders that may impede the long-term success of the therapy. Physicians must confirm that multiple classes of medication (antipsychotics, dopamine depleters, alpha1 agonists) and behavioral therapy have been administered (or are contraindicated) before prescribing DBS for tics.
The practice guideline was developed with financial support from AAN. Dr. Pringsheim reported no disclosures. Dr. Piacentini reported receiving funding for travel and speaking from foundations and universities and has received royalties from publishers. In addition, he has performed behavior therapy for tics for approximately 50% of his clinical time and has received financial or material support from Pfizer, the National Institute of Mental Health, and foundations.
SOURCE: Pringsheim T et al. Neurology. 2019 May 6. doi: 10.1212/WNL.0000000000007466.
REPORTING FROM AAN 2019
Aspirin did not improve sensitivity of fecal immunochemical test
The study was inspired by an observational study in which the sensitivity of the fecal immunochemical test (FIT) was enhanced in adults taking aspirin for cardiovascular disease prevention.
It was surmised that “aspirin predisposes to subclinical bleeding and, hence, increased detection of advanced adenomas by FIT. This suggests that administration of aspirin prior to fecal sampling might be a practical intervention to increase FIT sensitivity,” wrote Hermann Brenner, MD, of the German Cancer Research Center, Heidelberg, and colleagues.
In a study published in JAMA, the researchers analyzed 2,134 adults aged 40-80 years who were scheduled for colonoscopy. The study participants, who had no recent use of aspirin or other drugs with antithrombotic effects, were randomized to a 300-mg aspirin tablet or a placebo tablet 2 days before stool samples were obtained. The average age of the participants was 60 years, and 78% of the colonoscopies were for primary screening.
Overall, 224 of the study participants had advanced neoplasms, including 216 individuals with advanced adenoma and 8 with colorectal cancer.
Sensitivity was not significantly different between the aspirin and placebo groups at either of two predefined cutoffs of 10.2-mcg Hb/g stool (40.2% and 30.4%, respectively) and 17-mcg Hb/g stool (28.6% and 22.5%, respectively).
Two serious adverse events occurred in the aspirin group but were not considered related to aspirin. No serious adverse events were reported in the placebo group.
Although the results do not support the findings from previous observational studies, they suggest the need for more research of the potential impact of aspirin on FIT sensitivity, the researchers said.
“This trial was designed to detect a 24% absolute increase in sensitivity and was not adequately powered to detect small differences that may nevertheless be clinically meaningful given the low morbidity observed, the low cost of a single dose of aspirin, and the ease of implementation of this intervention across health systems,” they explained.
Additional limitations of the study included lack of adjustment for multiple testing in secondary analyses, inability to analyze subtypes of advanced neoplasms, and the inclusion of only one round of screening. FIT programs usually include multiple rounds, the researchers said. Therefore, “potential effects on detection of advanced neoplasms and reduction of CRC incidence and mortality in the long run are yet to be determined.”
SOURCE: Brenner H et al. JAMA. 2019;321(17):1686-1692.
The study was inspired by an observational study in which the sensitivity of the fecal immunochemical test (FIT) was enhanced in adults taking aspirin for cardiovascular disease prevention.
It was surmised that “aspirin predisposes to subclinical bleeding and, hence, increased detection of advanced adenomas by FIT. This suggests that administration of aspirin prior to fecal sampling might be a practical intervention to increase FIT sensitivity,” wrote Hermann Brenner, MD, of the German Cancer Research Center, Heidelberg, and colleagues.
In a study published in JAMA, the researchers analyzed 2,134 adults aged 40-80 years who were scheduled for colonoscopy. The study participants, who had no recent use of aspirin or other drugs with antithrombotic effects, were randomized to a 300-mg aspirin tablet or a placebo tablet 2 days before stool samples were obtained. The average age of the participants was 60 years, and 78% of the colonoscopies were for primary screening.
Overall, 224 of the study participants had advanced neoplasms, including 216 individuals with advanced adenoma and 8 with colorectal cancer.
Sensitivity was not significantly different between the aspirin and placebo groups at either of two predefined cutoffs of 10.2-mcg Hb/g stool (40.2% and 30.4%, respectively) and 17-mcg Hb/g stool (28.6% and 22.5%, respectively).
Two serious adverse events occurred in the aspirin group but were not considered related to aspirin. No serious adverse events were reported in the placebo group.
Although the results do not support the findings from previous observational studies, they suggest the need for more research of the potential impact of aspirin on FIT sensitivity, the researchers said.
“This trial was designed to detect a 24% absolute increase in sensitivity and was not adequately powered to detect small differences that may nevertheless be clinically meaningful given the low morbidity observed, the low cost of a single dose of aspirin, and the ease of implementation of this intervention across health systems,” they explained.
Additional limitations of the study included lack of adjustment for multiple testing in secondary analyses, inability to analyze subtypes of advanced neoplasms, and the inclusion of only one round of screening. FIT programs usually include multiple rounds, the researchers said. Therefore, “potential effects on detection of advanced neoplasms and reduction of CRC incidence and mortality in the long run are yet to be determined.”
SOURCE: Brenner H et al. JAMA. 2019;321(17):1686-1692.
The study was inspired by an observational study in which the sensitivity of the fecal immunochemical test (FIT) was enhanced in adults taking aspirin for cardiovascular disease prevention.
It was surmised that “aspirin predisposes to subclinical bleeding and, hence, increased detection of advanced adenomas by FIT. This suggests that administration of aspirin prior to fecal sampling might be a practical intervention to increase FIT sensitivity,” wrote Hermann Brenner, MD, of the German Cancer Research Center, Heidelberg, and colleagues.
In a study published in JAMA, the researchers analyzed 2,134 adults aged 40-80 years who were scheduled for colonoscopy. The study participants, who had no recent use of aspirin or other drugs with antithrombotic effects, were randomized to a 300-mg aspirin tablet or a placebo tablet 2 days before stool samples were obtained. The average age of the participants was 60 years, and 78% of the colonoscopies were for primary screening.
Overall, 224 of the study participants had advanced neoplasms, including 216 individuals with advanced adenoma and 8 with colorectal cancer.
Sensitivity was not significantly different between the aspirin and placebo groups at either of two predefined cutoffs of 10.2-mcg Hb/g stool (40.2% and 30.4%, respectively) and 17-mcg Hb/g stool (28.6% and 22.5%, respectively).
Two serious adverse events occurred in the aspirin group but were not considered related to aspirin. No serious adverse events were reported in the placebo group.
Although the results do not support the findings from previous observational studies, they suggest the need for more research of the potential impact of aspirin on FIT sensitivity, the researchers said.
“This trial was designed to detect a 24% absolute increase in sensitivity and was not adequately powered to detect small differences that may nevertheless be clinically meaningful given the low morbidity observed, the low cost of a single dose of aspirin, and the ease of implementation of this intervention across health systems,” they explained.
Additional limitations of the study included lack of adjustment for multiple testing in secondary analyses, inability to analyze subtypes of advanced neoplasms, and the inclusion of only one round of screening. FIT programs usually include multiple rounds, the researchers said. Therefore, “potential effects on detection of advanced neoplasms and reduction of CRC incidence and mortality in the long run are yet to be determined.”
SOURCE: Brenner H et al. JAMA. 2019;321(17):1686-1692.
FROM JAMA
Key clinical point: A dose of aspirin did not improve fecal immunochemical test (FIT) sensitivity to detect colorectal neoplasms in adults with no recent use of aspirin or other drugs with antithrombotic effects.
Major finding: Sensitivity of the FIT test was 40% in the aspirin group and 30% in the placebo group, a nonsignificant difference.
Study details: The data come from a randomized trial of 2,134 adults who received aspirin or placebo 2 days before stool sampling for FIT. The study participants were scheduled for colonoscopy at 14 gastroenterology practices and 4 hospitals in Germany.
Disclosures: Lead author Dr. Brenner disclosed grants from the German Federal Ministry of Education and Research, which funded the study, as well as the German Cancer Aid, the European Commission, the U.S. National Institutes of Health, Applied Proteomics, Roche Diagnostics, Volition, and Goodgut during the study period.
Source: Brenner H et al. JAMA. 2019;321(17):1686-92.
Product News May 2019
Altreno Lotion Now Available for Acne
Ortho Dermatologics launches Altreno (tretinoin) Lotion 0.05% for the treatment of acne in patients 9 years and older. Altreno was designed for women with adult acne, providing efficacy and tolerability in an elegant lotion formulation with once-daily dosing. Altreno Lotion is formulated with soluble collagen, glycerin, and sodium hyaluronate, which hydrate the skin. For more information visit www.altreno.com.
Avène XeraCalm A.D Soothes Dry Skin
Pierre Fabre Dermo-Cosmetique USA introduces new XeraCalm A.D products formulated for dry skin prone to itching and/or atopic dermatitis. The XeraCalm A.D line includes the Lipid-Replenishing Balm and the Lipid-Replenishing Cream, both with the new D.E.F.I. (Device for Exclusive Formula Integrity) pump to dispense the sterile formula and block allergens, bacteria, or air that could compromise safety and efficacy. The line also includes the Lipid-Replenishing Cleansing Oil and the new Ultra-Rich Cleansing Bar. For more information visit www.AveneUSA.com.
Duobrii Receives FDA Approval for Psoriasis
Ortho Dermatologics announces US Food and Drug Administration approval of the New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045% for treatment of plaque psoriasis in adults. Duobrii provides the benefits of combination therapy with a potent topical corticosteroid and a topical retinoid. Duobrii is expected to be available in June 2019. For more information visit www.duobriilotion.com.
Dupixent Approved for Atopic Dermatitis in Adolescents
sanofi-aventis and Regeneron Pharmaceuticals, Inc, announce US Food and Drug Administration approval of Dupixent (dupilumab) for adolescent patients aged 12 to 17 years with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is a targeted biologic therapy that inhibits signaling of IL-4 and IL-13, which play a role in the inflammation underlying AD. It reduces the extent and severity of AD and itching. Dupixent also is indicated for adult patients with AD. For more information visit www.dupixentHCP.com.
Jeuveau Approved for Glabellar Lines
Evolus, Inc, announces US Food and Drug Administration approval of Jeuveau (prabotulinumtoxinA-xvfs), an acetylcholine release inhibitor and neuromuscular blocking agent, for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. Jeuveau will be available in spring 2019. For more information visit www.evolus.com.
Ortho Dermatologics Cash-Pay Prescription Program Offers Predictable Prices
Ortho Dermatologics launches a cash-pay prescription program that will provide physicians and patients with direct access to many branded products at predictable prices ($50 to $115). The cash-pay prescription program gives patients access to treatments for acne, actinic keratosis and superficial basal cell carcinoma, barrier repair (eg, eczema treatments), wounds, and corticosteroid-responsive diseases and atopic dermatitis at a fixed price without the need for insurance, co-pay cards, or prior authorizations. After the physician issues an e-prescription, the product is shipped to the patient's home within 48 hours. Ortho Dermatologics plans to include approximately 20 products in the program over the next 18 months. There currently are 11 products available. For more information visit www.dermatology.com.
The Skin Cancer Foundation Awards 3 Research Grants
The Skin Cancer Foundation announces the winners of its annual research grant awards. The foundation awarded $125,000 total to 3 separate projects to support dermatology department research and clinical studies related to skin cancer. The 2019 recipients were Stephanie Savory, MD; Shruti Naik, PhD; and Rie Takahashi, MD, PhD. For more information visit www.SkinCancer.org/research.
The Skin Cancer Foundation Introduces NMSC Digital Publication
The Skin Cancer Foundation launches Carcinomas & Keratoses, a digital publication that sheds light on the most recent and important developments in keratinocyte cancers and precancers (nonmelanoma skin cancer), including basal cell carcinoma, cutaneous squamous cell carcinoma, and actinic keratosis. The publication features content written by dermatologists and the foundation's editorial team. Désirée Ratner, MD, will serve as Editor-in-Chief. For more information visit www.CarcinomasandKeratoses.org.
Tremfya One-Press Injector Approved for Plaque Psoriasis
Janssen Biotech, Inc, announces US Food and Drug Administration approval of Tremfya (guselkumab), a single-dose, patient-controlled, One-Press injector for adults with moderate to severe plaque psoriasis. The One-Press injector allows patients to control the rate and pressure of their injection, and it hides the needle throughout the process. Tremfya is an IL-23 blocker administered as a 100-mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. For more information visit www.tremfyahcp.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Altreno Lotion Now Available for Acne
Ortho Dermatologics launches Altreno (tretinoin) Lotion 0.05% for the treatment of acne in patients 9 years and older. Altreno was designed for women with adult acne, providing efficacy and tolerability in an elegant lotion formulation with once-daily dosing. Altreno Lotion is formulated with soluble collagen, glycerin, and sodium hyaluronate, which hydrate the skin. For more information visit www.altreno.com.
Avène XeraCalm A.D Soothes Dry Skin
Pierre Fabre Dermo-Cosmetique USA introduces new XeraCalm A.D products formulated for dry skin prone to itching and/or atopic dermatitis. The XeraCalm A.D line includes the Lipid-Replenishing Balm and the Lipid-Replenishing Cream, both with the new D.E.F.I. (Device for Exclusive Formula Integrity) pump to dispense the sterile formula and block allergens, bacteria, or air that could compromise safety and efficacy. The line also includes the Lipid-Replenishing Cleansing Oil and the new Ultra-Rich Cleansing Bar. For more information visit www.AveneUSA.com.
Duobrii Receives FDA Approval for Psoriasis
Ortho Dermatologics announces US Food and Drug Administration approval of the New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045% for treatment of plaque psoriasis in adults. Duobrii provides the benefits of combination therapy with a potent topical corticosteroid and a topical retinoid. Duobrii is expected to be available in June 2019. For more information visit www.duobriilotion.com.
Dupixent Approved for Atopic Dermatitis in Adolescents
sanofi-aventis and Regeneron Pharmaceuticals, Inc, announce US Food and Drug Administration approval of Dupixent (dupilumab) for adolescent patients aged 12 to 17 years with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is a targeted biologic therapy that inhibits signaling of IL-4 and IL-13, which play a role in the inflammation underlying AD. It reduces the extent and severity of AD and itching. Dupixent also is indicated for adult patients with AD. For more information visit www.dupixentHCP.com.
Jeuveau Approved for Glabellar Lines
Evolus, Inc, announces US Food and Drug Administration approval of Jeuveau (prabotulinumtoxinA-xvfs), an acetylcholine release inhibitor and neuromuscular blocking agent, for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. Jeuveau will be available in spring 2019. For more information visit www.evolus.com.
Ortho Dermatologics Cash-Pay Prescription Program Offers Predictable Prices
Ortho Dermatologics launches a cash-pay prescription program that will provide physicians and patients with direct access to many branded products at predictable prices ($50 to $115). The cash-pay prescription program gives patients access to treatments for acne, actinic keratosis and superficial basal cell carcinoma, barrier repair (eg, eczema treatments), wounds, and corticosteroid-responsive diseases and atopic dermatitis at a fixed price without the need for insurance, co-pay cards, or prior authorizations. After the physician issues an e-prescription, the product is shipped to the patient's home within 48 hours. Ortho Dermatologics plans to include approximately 20 products in the program over the next 18 months. There currently are 11 products available. For more information visit www.dermatology.com.
The Skin Cancer Foundation Awards 3 Research Grants
The Skin Cancer Foundation announces the winners of its annual research grant awards. The foundation awarded $125,000 total to 3 separate projects to support dermatology department research and clinical studies related to skin cancer. The 2019 recipients were Stephanie Savory, MD; Shruti Naik, PhD; and Rie Takahashi, MD, PhD. For more information visit www.SkinCancer.org/research.
The Skin Cancer Foundation Introduces NMSC Digital Publication
The Skin Cancer Foundation launches Carcinomas & Keratoses, a digital publication that sheds light on the most recent and important developments in keratinocyte cancers and precancers (nonmelanoma skin cancer), including basal cell carcinoma, cutaneous squamous cell carcinoma, and actinic keratosis. The publication features content written by dermatologists and the foundation's editorial team. Désirée Ratner, MD, will serve as Editor-in-Chief. For more information visit www.CarcinomasandKeratoses.org.
Tremfya One-Press Injector Approved for Plaque Psoriasis
Janssen Biotech, Inc, announces US Food and Drug Administration approval of Tremfya (guselkumab), a single-dose, patient-controlled, One-Press injector for adults with moderate to severe plaque psoriasis. The One-Press injector allows patients to control the rate and pressure of their injection, and it hides the needle throughout the process. Tremfya is an IL-23 blocker administered as a 100-mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. For more information visit www.tremfyahcp.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Altreno Lotion Now Available for Acne
Ortho Dermatologics launches Altreno (tretinoin) Lotion 0.05% for the treatment of acne in patients 9 years and older. Altreno was designed for women with adult acne, providing efficacy and tolerability in an elegant lotion formulation with once-daily dosing. Altreno Lotion is formulated with soluble collagen, glycerin, and sodium hyaluronate, which hydrate the skin. For more information visit www.altreno.com.
Avène XeraCalm A.D Soothes Dry Skin
Pierre Fabre Dermo-Cosmetique USA introduces new XeraCalm A.D products formulated for dry skin prone to itching and/or atopic dermatitis. The XeraCalm A.D line includes the Lipid-Replenishing Balm and the Lipid-Replenishing Cream, both with the new D.E.F.I. (Device for Exclusive Formula Integrity) pump to dispense the sterile formula and block allergens, bacteria, or air that could compromise safety and efficacy. The line also includes the Lipid-Replenishing Cleansing Oil and the new Ultra-Rich Cleansing Bar. For more information visit www.AveneUSA.com.
Duobrii Receives FDA Approval for Psoriasis
Ortho Dermatologics announces US Food and Drug Administration approval of the New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045% for treatment of plaque psoriasis in adults. Duobrii provides the benefits of combination therapy with a potent topical corticosteroid and a topical retinoid. Duobrii is expected to be available in June 2019. For more information visit www.duobriilotion.com.
Dupixent Approved for Atopic Dermatitis in Adolescents
sanofi-aventis and Regeneron Pharmaceuticals, Inc, announce US Food and Drug Administration approval of Dupixent (dupilumab) for adolescent patients aged 12 to 17 years with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is a targeted biologic therapy that inhibits signaling of IL-4 and IL-13, which play a role in the inflammation underlying AD. It reduces the extent and severity of AD and itching. Dupixent also is indicated for adult patients with AD. For more information visit www.dupixentHCP.com.
Jeuveau Approved for Glabellar Lines
Evolus, Inc, announces US Food and Drug Administration approval of Jeuveau (prabotulinumtoxinA-xvfs), an acetylcholine release inhibitor and neuromuscular blocking agent, for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. Jeuveau will be available in spring 2019. For more information visit www.evolus.com.
Ortho Dermatologics Cash-Pay Prescription Program Offers Predictable Prices
Ortho Dermatologics launches a cash-pay prescription program that will provide physicians and patients with direct access to many branded products at predictable prices ($50 to $115). The cash-pay prescription program gives patients access to treatments for acne, actinic keratosis and superficial basal cell carcinoma, barrier repair (eg, eczema treatments), wounds, and corticosteroid-responsive diseases and atopic dermatitis at a fixed price without the need for insurance, co-pay cards, or prior authorizations. After the physician issues an e-prescription, the product is shipped to the patient's home within 48 hours. Ortho Dermatologics plans to include approximately 20 products in the program over the next 18 months. There currently are 11 products available. For more information visit www.dermatology.com.
The Skin Cancer Foundation Awards 3 Research Grants
The Skin Cancer Foundation announces the winners of its annual research grant awards. The foundation awarded $125,000 total to 3 separate projects to support dermatology department research and clinical studies related to skin cancer. The 2019 recipients were Stephanie Savory, MD; Shruti Naik, PhD; and Rie Takahashi, MD, PhD. For more information visit www.SkinCancer.org/research.
The Skin Cancer Foundation Introduces NMSC Digital Publication
The Skin Cancer Foundation launches Carcinomas & Keratoses, a digital publication that sheds light on the most recent and important developments in keratinocyte cancers and precancers (nonmelanoma skin cancer), including basal cell carcinoma, cutaneous squamous cell carcinoma, and actinic keratosis. The publication features content written by dermatologists and the foundation's editorial team. Désirée Ratner, MD, will serve as Editor-in-Chief. For more information visit www.CarcinomasandKeratoses.org.
Tremfya One-Press Injector Approved for Plaque Psoriasis
Janssen Biotech, Inc, announces US Food and Drug Administration approval of Tremfya (guselkumab), a single-dose, patient-controlled, One-Press injector for adults with moderate to severe plaque psoriasis. The One-Press injector allows patients to control the rate and pressure of their injection, and it hides the needle throughout the process. Tremfya is an IL-23 blocker administered as a 100-mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. For more information visit www.tremfyahcp.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Criterion based on the central vein sign distinguishes between MS and mimics
PHILADELPHIA – according to research presented at the annual meeting of the American Academy of Neurology. Using this criterion in clinical practice is feasible, the researchers added.
Several years ago, researchers proposed the central vein sign as a specific and sensitive imaging biomarker for distinguishing between multiple sclerosis (MS) and its imaging mimics. Recent studies have proposed criteria for this distinction that are based on the proportion of lesions with the central vein sign. Criteria that are based on the absolute numbers of lesions with the central vein sign, however, may be more applicable in clinical practice, said Tim Sinnecker, MD, research associate at the University of Basel (Switzerland).
Dr. Sinnecker and colleagues conducted a multicenter study to evaluate the sensitivity and specificity of criteria that are based on the absolute numbers of lesions with the central vein sign (CVS) in distinguishing MS from non-MS conditions on clinical 3T brain MRI. They analyzed 606 participants with clinically isolated syndrome (CIS; n = 117), relapsing remitting MS (RRMS; n = 236, of whom 108 had a disease duration shorter than 5 years), aquaporin 4 antibody–positive neuromyelitis optica spectrum disorder (n = 32), systemic lupus erythematosus (n = 25), migraine (n = 29), cluster headache (n = 5), diabetes mellitus (n = 20), or other types of small-vessel disease (n = 142). Raters blinded to clinical data and lesion distribution determined the occurrence of CVS on 3T T2*-weighted or susceptibility-weighted imaging. The researchers assessed the sensitivity and specificity of different CVS lesion criteria that were defined according to the absolute numbers of lesions with CVS.
In total, Dr. Sinnecker and colleagues analyzed 4,447 lesions. The “two-CVS-lesions criterion” (two or more lesions with CVS) had a sensitivity and specificity of 76.2% and 79.3%, respectively, in distinguishing between RRMS/CIS and non-MS. The “three-CVS-lesions criterion” (three or more lesions with CVS) had a sensitivity and specificity of 61.9% and 89.0%, respectively. The observed sensitivity and specificity values were consistent across all disease subgroups examined in the study, including CIS and early RRMS. These results indicate that positive criteria based on CVS could be used to support the diagnosis of MS, Dr. Sinnecker said.
Dr. Sinnecker reported receiving personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion.
SOURCE: Sinnecker T et al. AAN 2019, Abstract S6.002.
PHILADELPHIA – according to research presented at the annual meeting of the American Academy of Neurology. Using this criterion in clinical practice is feasible, the researchers added.
Several years ago, researchers proposed the central vein sign as a specific and sensitive imaging biomarker for distinguishing between multiple sclerosis (MS) and its imaging mimics. Recent studies have proposed criteria for this distinction that are based on the proportion of lesions with the central vein sign. Criteria that are based on the absolute numbers of lesions with the central vein sign, however, may be more applicable in clinical practice, said Tim Sinnecker, MD, research associate at the University of Basel (Switzerland).
Dr. Sinnecker and colleagues conducted a multicenter study to evaluate the sensitivity and specificity of criteria that are based on the absolute numbers of lesions with the central vein sign (CVS) in distinguishing MS from non-MS conditions on clinical 3T brain MRI. They analyzed 606 participants with clinically isolated syndrome (CIS; n = 117), relapsing remitting MS (RRMS; n = 236, of whom 108 had a disease duration shorter than 5 years), aquaporin 4 antibody–positive neuromyelitis optica spectrum disorder (n = 32), systemic lupus erythematosus (n = 25), migraine (n = 29), cluster headache (n = 5), diabetes mellitus (n = 20), or other types of small-vessel disease (n = 142). Raters blinded to clinical data and lesion distribution determined the occurrence of CVS on 3T T2*-weighted or susceptibility-weighted imaging. The researchers assessed the sensitivity and specificity of different CVS lesion criteria that were defined according to the absolute numbers of lesions with CVS.
In total, Dr. Sinnecker and colleagues analyzed 4,447 lesions. The “two-CVS-lesions criterion” (two or more lesions with CVS) had a sensitivity and specificity of 76.2% and 79.3%, respectively, in distinguishing between RRMS/CIS and non-MS. The “three-CVS-lesions criterion” (three or more lesions with CVS) had a sensitivity and specificity of 61.9% and 89.0%, respectively. The observed sensitivity and specificity values were consistent across all disease subgroups examined in the study, including CIS and early RRMS. These results indicate that positive criteria based on CVS could be used to support the diagnosis of MS, Dr. Sinnecker said.
Dr. Sinnecker reported receiving personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion.
SOURCE: Sinnecker T et al. AAN 2019, Abstract S6.002.
PHILADELPHIA – according to research presented at the annual meeting of the American Academy of Neurology. Using this criterion in clinical practice is feasible, the researchers added.
Several years ago, researchers proposed the central vein sign as a specific and sensitive imaging biomarker for distinguishing between multiple sclerosis (MS) and its imaging mimics. Recent studies have proposed criteria for this distinction that are based on the proportion of lesions with the central vein sign. Criteria that are based on the absolute numbers of lesions with the central vein sign, however, may be more applicable in clinical practice, said Tim Sinnecker, MD, research associate at the University of Basel (Switzerland).
Dr. Sinnecker and colleagues conducted a multicenter study to evaluate the sensitivity and specificity of criteria that are based on the absolute numbers of lesions with the central vein sign (CVS) in distinguishing MS from non-MS conditions on clinical 3T brain MRI. They analyzed 606 participants with clinically isolated syndrome (CIS; n = 117), relapsing remitting MS (RRMS; n = 236, of whom 108 had a disease duration shorter than 5 years), aquaporin 4 antibody–positive neuromyelitis optica spectrum disorder (n = 32), systemic lupus erythematosus (n = 25), migraine (n = 29), cluster headache (n = 5), diabetes mellitus (n = 20), or other types of small-vessel disease (n = 142). Raters blinded to clinical data and lesion distribution determined the occurrence of CVS on 3T T2*-weighted or susceptibility-weighted imaging. The researchers assessed the sensitivity and specificity of different CVS lesion criteria that were defined according to the absolute numbers of lesions with CVS.
In total, Dr. Sinnecker and colleagues analyzed 4,447 lesions. The “two-CVS-lesions criterion” (two or more lesions with CVS) had a sensitivity and specificity of 76.2% and 79.3%, respectively, in distinguishing between RRMS/CIS and non-MS. The “three-CVS-lesions criterion” (three or more lesions with CVS) had a sensitivity and specificity of 61.9% and 89.0%, respectively. The observed sensitivity and specificity values were consistent across all disease subgroups examined in the study, including CIS and early RRMS. These results indicate that positive criteria based on CVS could be used to support the diagnosis of MS, Dr. Sinnecker said.
Dr. Sinnecker reported receiving personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion.
SOURCE: Sinnecker T et al. AAN 2019, Abstract S6.002.
REPORTING FROM AAN 2019
The search for a life-changing innovation
It might be the ultimate medical innovation – an artificial heart – and generations of physicians have pursued it, a story told in “Ticker: The Quest to Create an Artificial Heart.”
Author Mimi Swartz feared this history was being forgotten. “The larger-than-life personalities – Dr. Michael DeBakey and Dr. Denton Cooley – were such dominant figures for more than 50 years; I couldn’t stand for that history to be lost,” she said. “Also, so many innovations happened in Houston, including the implantation of the first artificial heart and the development of the Left Ventricular Assist Device – I couldn’t stand for that information to be lost too.”
Writing this book taught her a lot about innovation in medicine, the trade-offs involved in medical progress, even who benefits most.
“One of the most important things to think about is how many of these high-tech devices we need, and who will get them – who will be able to afford them,” she said.
“Medical innovation over the last 50 years is a global, billion dollar business, fraught with pitfalls: legal, governmental, ethical, financial, and, finally, personal,” Ms. Swartz said. “A great invention that could save millions of lives can end up on the junk heap because a hedge fund lost interest, while another great invention moves forward, but was stolen from the lab of another researcher. The persistence required to bring a medical device to market is daunting. One inventor told me, ‘If I’d known what was going to happen, I never would have even started.’ ”
Reference
Swartz M. Ticker: The Quest to Create an Artificial Heart. New York: Penguin Random House, 2018.
It might be the ultimate medical innovation – an artificial heart – and generations of physicians have pursued it, a story told in “Ticker: The Quest to Create an Artificial Heart.”
Author Mimi Swartz feared this history was being forgotten. “The larger-than-life personalities – Dr. Michael DeBakey and Dr. Denton Cooley – were such dominant figures for more than 50 years; I couldn’t stand for that history to be lost,” she said. “Also, so many innovations happened in Houston, including the implantation of the first artificial heart and the development of the Left Ventricular Assist Device – I couldn’t stand for that information to be lost too.”
Writing this book taught her a lot about innovation in medicine, the trade-offs involved in medical progress, even who benefits most.
“One of the most important things to think about is how many of these high-tech devices we need, and who will get them – who will be able to afford them,” she said.
“Medical innovation over the last 50 years is a global, billion dollar business, fraught with pitfalls: legal, governmental, ethical, financial, and, finally, personal,” Ms. Swartz said. “A great invention that could save millions of lives can end up on the junk heap because a hedge fund lost interest, while another great invention moves forward, but was stolen from the lab of another researcher. The persistence required to bring a medical device to market is daunting. One inventor told me, ‘If I’d known what was going to happen, I never would have even started.’ ”
Reference
Swartz M. Ticker: The Quest to Create an Artificial Heart. New York: Penguin Random House, 2018.
It might be the ultimate medical innovation – an artificial heart – and generations of physicians have pursued it, a story told in “Ticker: The Quest to Create an Artificial Heart.”
Author Mimi Swartz feared this history was being forgotten. “The larger-than-life personalities – Dr. Michael DeBakey and Dr. Denton Cooley – were such dominant figures for more than 50 years; I couldn’t stand for that history to be lost,” she said. “Also, so many innovations happened in Houston, including the implantation of the first artificial heart and the development of the Left Ventricular Assist Device – I couldn’t stand for that information to be lost too.”
Writing this book taught her a lot about innovation in medicine, the trade-offs involved in medical progress, even who benefits most.
“One of the most important things to think about is how many of these high-tech devices we need, and who will get them – who will be able to afford them,” she said.
“Medical innovation over the last 50 years is a global, billion dollar business, fraught with pitfalls: legal, governmental, ethical, financial, and, finally, personal,” Ms. Swartz said. “A great invention that could save millions of lives can end up on the junk heap because a hedge fund lost interest, while another great invention moves forward, but was stolen from the lab of another researcher. The persistence required to bring a medical device to market is daunting. One inventor told me, ‘If I’d known what was going to happen, I never would have even started.’ ”
Reference
Swartz M. Ticker: The Quest to Create an Artificial Heart. New York: Penguin Random House, 2018.
Laquinimod may not improve motor function in Huntington’s disease
PHILADELPHIA – Laquinimod appears not to improve motor function or clinical outcomes in patients with Huntington’s disease, according to a study presented at the annual meeting of the American Academy of Neurology. However, the drug reduced brain volume loss in the caudate and other regions.
Laquinimod is an investigational immunomodulatory drug that prevents inflammation and neurodegeneration in the CNS. The treatment was studied as a therapy for multiple sclerosis (MS), but development for this indication has been stopped. Researchers have observed that laquinimod modulates inflammatory pathways that are involved in Huntington’s disease pathology.
Ralf Reilmann, MD, PhD, founder of the George Huntington Institute and chair of the Huntington unit at the University of Münster (Germany), and colleagues conducted the phase 2 LEGATO-HD study at 48 sites in 10 countries to examine the efficacy and safety of laquinimod in patients with early Huntington’s disease. Participants were randomized in double-blind fashion to daily placebo or 0.5-mg, 1.0-mg, or 1.5-mg doses of laquinimod for 52 weeks. After the initiation of this trial, studies of the drug in MS indicated that the 1.5-mg dose was associated with cardiovascular risks, and Dr. Reilmann and his colleagues discontinued the 1.5-mg arm of their trial as a precaution.
The primary endpoint of LEGATO-HD was the change from baseline in the Unified Huntington’s Disease Rating Scale (UHDRS)–Total Motor Score (TMS). The secondary endpoint was the percent change in caudate volume at week 52 for the 1.0-mg dose group, compared with controls. The investigators also examined exploratory endpoints such as changes in MRI volume measures and Quantitative Motor, Clinician Interview-Based Impression of Change plus caregiver input, UHDRS–Total Functional Capacity and UHDRS–Functional Assessment scores. Adverse event reporting and clinical and laboratory examinations constituted the safety measures.
Dr. Reilmann and colleagues found no difference between the treated patients and controls in UHDRS-TMS. However, they did observe less caudate volume loss in the laquinimod group, compared with controls. All MRI exploratory measures also favored laquinimod. The researchers found no treatment effects of laquinimod in rater-dependent clinical outcome measures. Laquinimod was well tolerated, and the study yielded no new safety findings.
Dr. Reilmann has received research support from Teva, which supported the LEGATO-HD trial and in 2018 sold development and commercial rights for laquinimod to Active Biotech. He has received research support from a variety of other pharmaceutical companies and organizations, including the CHDI Foundation and the European Huntington Disease Network.
SOURCE: Reilmann R et al. AAN 2019, Abstract S16.007.
PHILADELPHIA – Laquinimod appears not to improve motor function or clinical outcomes in patients with Huntington’s disease, according to a study presented at the annual meeting of the American Academy of Neurology. However, the drug reduced brain volume loss in the caudate and other regions.
Laquinimod is an investigational immunomodulatory drug that prevents inflammation and neurodegeneration in the CNS. The treatment was studied as a therapy for multiple sclerosis (MS), but development for this indication has been stopped. Researchers have observed that laquinimod modulates inflammatory pathways that are involved in Huntington’s disease pathology.
Ralf Reilmann, MD, PhD, founder of the George Huntington Institute and chair of the Huntington unit at the University of Münster (Germany), and colleagues conducted the phase 2 LEGATO-HD study at 48 sites in 10 countries to examine the efficacy and safety of laquinimod in patients with early Huntington’s disease. Participants were randomized in double-blind fashion to daily placebo or 0.5-mg, 1.0-mg, or 1.5-mg doses of laquinimod for 52 weeks. After the initiation of this trial, studies of the drug in MS indicated that the 1.5-mg dose was associated with cardiovascular risks, and Dr. Reilmann and his colleagues discontinued the 1.5-mg arm of their trial as a precaution.
The primary endpoint of LEGATO-HD was the change from baseline in the Unified Huntington’s Disease Rating Scale (UHDRS)–Total Motor Score (TMS). The secondary endpoint was the percent change in caudate volume at week 52 for the 1.0-mg dose group, compared with controls. The investigators also examined exploratory endpoints such as changes in MRI volume measures and Quantitative Motor, Clinician Interview-Based Impression of Change plus caregiver input, UHDRS–Total Functional Capacity and UHDRS–Functional Assessment scores. Adverse event reporting and clinical and laboratory examinations constituted the safety measures.
Dr. Reilmann and colleagues found no difference between the treated patients and controls in UHDRS-TMS. However, they did observe less caudate volume loss in the laquinimod group, compared with controls. All MRI exploratory measures also favored laquinimod. The researchers found no treatment effects of laquinimod in rater-dependent clinical outcome measures. Laquinimod was well tolerated, and the study yielded no new safety findings.
Dr. Reilmann has received research support from Teva, which supported the LEGATO-HD trial and in 2018 sold development and commercial rights for laquinimod to Active Biotech. He has received research support from a variety of other pharmaceutical companies and organizations, including the CHDI Foundation and the European Huntington Disease Network.
SOURCE: Reilmann R et al. AAN 2019, Abstract S16.007.
PHILADELPHIA – Laquinimod appears not to improve motor function or clinical outcomes in patients with Huntington’s disease, according to a study presented at the annual meeting of the American Academy of Neurology. However, the drug reduced brain volume loss in the caudate and other regions.
Laquinimod is an investigational immunomodulatory drug that prevents inflammation and neurodegeneration in the CNS. The treatment was studied as a therapy for multiple sclerosis (MS), but development for this indication has been stopped. Researchers have observed that laquinimod modulates inflammatory pathways that are involved in Huntington’s disease pathology.
Ralf Reilmann, MD, PhD, founder of the George Huntington Institute and chair of the Huntington unit at the University of Münster (Germany), and colleagues conducted the phase 2 LEGATO-HD study at 48 sites in 10 countries to examine the efficacy and safety of laquinimod in patients with early Huntington’s disease. Participants were randomized in double-blind fashion to daily placebo or 0.5-mg, 1.0-mg, or 1.5-mg doses of laquinimod for 52 weeks. After the initiation of this trial, studies of the drug in MS indicated that the 1.5-mg dose was associated with cardiovascular risks, and Dr. Reilmann and his colleagues discontinued the 1.5-mg arm of their trial as a precaution.
The primary endpoint of LEGATO-HD was the change from baseline in the Unified Huntington’s Disease Rating Scale (UHDRS)–Total Motor Score (TMS). The secondary endpoint was the percent change in caudate volume at week 52 for the 1.0-mg dose group, compared with controls. The investigators also examined exploratory endpoints such as changes in MRI volume measures and Quantitative Motor, Clinician Interview-Based Impression of Change plus caregiver input, UHDRS–Total Functional Capacity and UHDRS–Functional Assessment scores. Adverse event reporting and clinical and laboratory examinations constituted the safety measures.
Dr. Reilmann and colleagues found no difference between the treated patients and controls in UHDRS-TMS. However, they did observe less caudate volume loss in the laquinimod group, compared with controls. All MRI exploratory measures also favored laquinimod. The researchers found no treatment effects of laquinimod in rater-dependent clinical outcome measures. Laquinimod was well tolerated, and the study yielded no new safety findings.
Dr. Reilmann has received research support from Teva, which supported the LEGATO-HD trial and in 2018 sold development and commercial rights for laquinimod to Active Biotech. He has received research support from a variety of other pharmaceutical companies and organizations, including the CHDI Foundation and the European Huntington Disease Network.
SOURCE: Reilmann R et al. AAN 2019, Abstract S16.007.
REPORTING FROM AAN 2019
Key clinical point: Investigators found no difference between laquinimod and placebo on motor function in Huntington’s disease.
Major finding: The study examined 0.5-mg, 1.0-mg, and 1.5-mg doses of laquinimod.
Study details: The phase 2 LEGATO-HD trial included 352 patients with Huntington’s disease who underwent a 52-week treatment period.
Disclosures: Dr. Reilmann has received research support from Teva, which supported the LEGATO-HD trial and in 2018, sold development and commercial rights for laquinimod to Active Biotech. He has received research support from a variety of other pharmaceutical companies and organizations, including the CHDI Foundation and the European Huntington Disease Network.
Source: Reilmann R et al. AAN 2019, Abstract S16.007.
Eculizumab cuts relapse risk in NMO spectrum disorder
PHILADELPHIA – Treatment with the monoclonal antibody eculizumab substantially reduced the risk of relapse versus placebo in patients with aquaporin-4 positive neuromyelitis optica (NMO) spectrum disorder, according to the results of a phase 3 trial reported at the annual meeting of the American Academy of Neurology. Nearly 98% of patients with this autoimmune inflammatory CNS disorder were relapse-free at 48 weeks in the PREVENT trial, according to principal investigator Sean J. Pittock, MD, director of the Mayo Clinic’s Center for Multiple Sclerosis and Autoimmune Neurology in Rochester, Minn.
“This was a dramatic result, I think, really showing a significant amount of hope for people with this disease,” Dr. Pittock said in a press conference.
Most cases of NMO are associated with aquaporin-4 antibodies and complement-mediated CNS damage, and eculizumab (Soliris) is an inhibitor of complement protein C5 shown to reduce relapse frequency in a previous, small open-label study, according to Dr. Pittock.
In the current global phase 3 trial, conducted at 70 centers in 18 countries, 143 adult patients with aquaporin-4 positive NMO spectrum disorder were randomized to eculizumab every 2 weeks or placebo. The trial allowed for supportive immunosuppressive therapy and excluded patients who had received rituximab in the past 3 months. A total of 124 patients completed the study, which was stopped after 23 adjudicated relapses had occurred.
Time to first adjudicated relapse on trial, the primary endpoint of the study, showed a significant effect (P less than .0001) in favor of monoclonal antibody treatment over placebo, with a 94.2% reduction in risk of relapse, according to Dr. Pittock and coinvestigators.
At 48 weeks, 97.9% of patients were relapse free in the eculizumab group, versus 63.2% in the placebo group, they added in their report, which was published May 3 online ahead of print in the New England Journal of Medicine (doi: 10.1056/NEJMoa1900866).
Longer-term follow-up showed that, at 144 weeks, 96% of eculizumab-treated patients remained relapse free, while 45% of the placebo group were relapse free, Dr. Pittock said in the press conference.
Most adverse events seen on treatment were mild to moderate, and no meningococcal infections were observed.
One death occurred in the study from pulmonary empyema in an eculizumab-treated patient, but the associated cultures yielded microorganisms not associated with complement deficiency, investigators said in their published report.
“The concept that you can discover a target, understand the immunopathology of a disease, identify a novel mechanism, then identify a precision drug that targets that mechanism, and essentially turn off, or switch off, the disease is very, very exciting,” Dr. Pittock said in the press conference.
The study was supported by Alexion Pharmaceuticals. Dr. Pittock provided disclosures related to Alexion Pharmaceuticals, MedImmune, and Grifols, along with patents related to administration of eculizumab and cancer markers in neuromyelitis optica.
SOURCE: Pittock SJ et al. AAN 2019, Emerging Science Abstract 009.
PHILADELPHIA – Treatment with the monoclonal antibody eculizumab substantially reduced the risk of relapse versus placebo in patients with aquaporin-4 positive neuromyelitis optica (NMO) spectrum disorder, according to the results of a phase 3 trial reported at the annual meeting of the American Academy of Neurology. Nearly 98% of patients with this autoimmune inflammatory CNS disorder were relapse-free at 48 weeks in the PREVENT trial, according to principal investigator Sean J. Pittock, MD, director of the Mayo Clinic’s Center for Multiple Sclerosis and Autoimmune Neurology in Rochester, Minn.
“This was a dramatic result, I think, really showing a significant amount of hope for people with this disease,” Dr. Pittock said in a press conference.
Most cases of NMO are associated with aquaporin-4 antibodies and complement-mediated CNS damage, and eculizumab (Soliris) is an inhibitor of complement protein C5 shown to reduce relapse frequency in a previous, small open-label study, according to Dr. Pittock.
In the current global phase 3 trial, conducted at 70 centers in 18 countries, 143 adult patients with aquaporin-4 positive NMO spectrum disorder were randomized to eculizumab every 2 weeks or placebo. The trial allowed for supportive immunosuppressive therapy and excluded patients who had received rituximab in the past 3 months. A total of 124 patients completed the study, which was stopped after 23 adjudicated relapses had occurred.
Time to first adjudicated relapse on trial, the primary endpoint of the study, showed a significant effect (P less than .0001) in favor of monoclonal antibody treatment over placebo, with a 94.2% reduction in risk of relapse, according to Dr. Pittock and coinvestigators.
At 48 weeks, 97.9% of patients were relapse free in the eculizumab group, versus 63.2% in the placebo group, they added in their report, which was published May 3 online ahead of print in the New England Journal of Medicine (doi: 10.1056/NEJMoa1900866).
Longer-term follow-up showed that, at 144 weeks, 96% of eculizumab-treated patients remained relapse free, while 45% of the placebo group were relapse free, Dr. Pittock said in the press conference.
Most adverse events seen on treatment were mild to moderate, and no meningococcal infections were observed.
One death occurred in the study from pulmonary empyema in an eculizumab-treated patient, but the associated cultures yielded microorganisms not associated with complement deficiency, investigators said in their published report.
“The concept that you can discover a target, understand the immunopathology of a disease, identify a novel mechanism, then identify a precision drug that targets that mechanism, and essentially turn off, or switch off, the disease is very, very exciting,” Dr. Pittock said in the press conference.
The study was supported by Alexion Pharmaceuticals. Dr. Pittock provided disclosures related to Alexion Pharmaceuticals, MedImmune, and Grifols, along with patents related to administration of eculizumab and cancer markers in neuromyelitis optica.
SOURCE: Pittock SJ et al. AAN 2019, Emerging Science Abstract 009.
PHILADELPHIA – Treatment with the monoclonal antibody eculizumab substantially reduced the risk of relapse versus placebo in patients with aquaporin-4 positive neuromyelitis optica (NMO) spectrum disorder, according to the results of a phase 3 trial reported at the annual meeting of the American Academy of Neurology. Nearly 98% of patients with this autoimmune inflammatory CNS disorder were relapse-free at 48 weeks in the PREVENT trial, according to principal investigator Sean J. Pittock, MD, director of the Mayo Clinic’s Center for Multiple Sclerosis and Autoimmune Neurology in Rochester, Minn.
“This was a dramatic result, I think, really showing a significant amount of hope for people with this disease,” Dr. Pittock said in a press conference.
Most cases of NMO are associated with aquaporin-4 antibodies and complement-mediated CNS damage, and eculizumab (Soliris) is an inhibitor of complement protein C5 shown to reduce relapse frequency in a previous, small open-label study, according to Dr. Pittock.
In the current global phase 3 trial, conducted at 70 centers in 18 countries, 143 adult patients with aquaporin-4 positive NMO spectrum disorder were randomized to eculizumab every 2 weeks or placebo. The trial allowed for supportive immunosuppressive therapy and excluded patients who had received rituximab in the past 3 months. A total of 124 patients completed the study, which was stopped after 23 adjudicated relapses had occurred.
Time to first adjudicated relapse on trial, the primary endpoint of the study, showed a significant effect (P less than .0001) in favor of monoclonal antibody treatment over placebo, with a 94.2% reduction in risk of relapse, according to Dr. Pittock and coinvestigators.
At 48 weeks, 97.9% of patients were relapse free in the eculizumab group, versus 63.2% in the placebo group, they added in their report, which was published May 3 online ahead of print in the New England Journal of Medicine (doi: 10.1056/NEJMoa1900866).
Longer-term follow-up showed that, at 144 weeks, 96% of eculizumab-treated patients remained relapse free, while 45% of the placebo group were relapse free, Dr. Pittock said in the press conference.
Most adverse events seen on treatment were mild to moderate, and no meningococcal infections were observed.
One death occurred in the study from pulmonary empyema in an eculizumab-treated patient, but the associated cultures yielded microorganisms not associated with complement deficiency, investigators said in their published report.
“The concept that you can discover a target, understand the immunopathology of a disease, identify a novel mechanism, then identify a precision drug that targets that mechanism, and essentially turn off, or switch off, the disease is very, very exciting,” Dr. Pittock said in the press conference.
The study was supported by Alexion Pharmaceuticals. Dr. Pittock provided disclosures related to Alexion Pharmaceuticals, MedImmune, and Grifols, along with patents related to administration of eculizumab and cancer markers in neuromyelitis optica.
SOURCE: Pittock SJ et al. AAN 2019, Emerging Science Abstract 009.
FROM AAN 2019
Key clinical point: Treatment with eculizumab substantially reduced risk of relapse versus placebo in patients with aquaporin-4 positive neuromyelitis optica spectrum disorder.
Major finding: Time to first adjudicated relapse on trial, the primary endpoint of the study, showed a significant (P less than .0001) effect in favor of monoclonal antibody treatment over placebo, with a 94.2% reduction in risk of relapse.
Study details: A phase 3, randomized, double-blind, placebo-controlled, multicenter trial (PREVENT) including 143 adult patients.
Disclosures: The study was supported by Alexion Pharmaceuticals. Dr. Pittock provided disclosures related to Alexion Pharmaceuticals, MedImmune, and Grifols, along with patents related to administration of eculizumab and cancer markers in neuromyelitis optica.
Source: Pittock SJ et al. AAN 2019, Emerging Science Abstract 009.
Fournier gangrene cases surge in patients using SGLT2 inhibitors
since the US Food and Drug Administration (FDA) issued a 2018 warning about this rare but serious infection, researchers say.
Health care providers prescribing SGLT2 inhibitors to patients with diabetes should have a high index of suspicion for the signs and symptoms of Fournier gangrene, given its substantial morbidity and mortality, according to Susan J. Bersoff-Matcha, MD, and her colleagues at the FDA.
“Although the risk for [Fournier gangrene] is low, serious infection should be considered and weighed against the benefits of SGLT2 inhibitor therapy,” said Dr. Bersoff-Matcha and co-authors in their recent report published in the Annals of Internal Medicine (2019 May 6. doi: 10.7326/M19-0085).
In the previous warning, FDA officials said 12 cases of Fournier gangrene in patients taking an SGLT2 inhibitor had been reported to the agency or in medical literature from March 2013, when the first such inhibitor was approved, and May 2018.
In this latest report, a total of 55 Fournier gangrene cases had been reported in patients receiving SGLT2 inhibitors from March 2, 2013 through January 31, 2019.
The influx of reports may have been prompted by growing awareness of the safety issue, investigators said, but could also reflect the increasing prevalence of diabetes combined with SGLT2 inhibitor use. The researchers also noted that diabetes is a comorbidity in 32% to 66% of cases of Fournier gangrene.
But the likliehood that diabetes mellitus alone causes Fournier gangrene seems unlikley, given that Dr. Bersoff-Matcha and co-authors only found 19 Fournier gangrene cases associated with other classes of antiglycemic agents reported to the FDA or in the literature over a 35-year time frame.
“If Fournier gangrene were associated only with diabetes mellitus and not SGLT2 inhibitors, we would expect far more cases reported with the other antiglycemic agents, considering the 35-year timeframe and the large number of agents,” they said in their report.
Cases were reported for all FDA-approved SGLT2 inhibitors besides ertugliflozin, an agent approved for use in the U.S. in December 2017. The lack of cases reported for this drug could be related to its limited time on the market, the investigators said.
Fournier gangrene, marked by rapidly progressing necrotizing infection of the genitalia, perineum, and perianal region, requires antibiotics and immediate surgery, according to Dr. Bersoff-Matcha and colleagues.
“Serious complications and death are likely if Fournier gangrene is not recognized immediately and surgical intervention is not carried out within the first few hours of diagnosis,” they said in the report.
Of the 55 cases reported in patients receiving SGLT2 inhibitors, 39 were men and 16 were women, with an average of 9 months from the start of treatment to the event, investigators said.
At least 25 patients required multiple surgeries, including one patient who had 17 trips to the operating room, they said. A total of 8 patients had a fecal diversion procedure, and 4 patients had skin grafting.
Six patients had multiple encounters with a provider before being diagnosed, suggesting that the provider may have not recognized the infection due to its nonspecific symptoms, which include fatigue, fever, and malaise.
“Pain that seems out of proportion to findings on physical examination is a strong clinical indicator of necrotizing fasciitis and may be the most important diagnostic clue,” Dr. Bersoff-Matcha and co-authors said in their report.
The incidence of Fournier gangrene in patients taking SGLT2 inhibitors can’t be established by these cases reported to the FDA, which are spontaneously provided by health care providers and patients, investigators said.
“We suspect that our numbers underestimate the true burden,” they said in their report.
Dr. Bersoff-Matcha and co-authors disclosed no conflicts of interest related to their report.
SOURCE: Bersoff-Matcha SJ, et al. Ann Intern Med. 2019 May 6. Doi: doi:10.7326/M19-0085.
This article was updated May 9, 2019.
since the US Food and Drug Administration (FDA) issued a 2018 warning about this rare but serious infection, researchers say.
Health care providers prescribing SGLT2 inhibitors to patients with diabetes should have a high index of suspicion for the signs and symptoms of Fournier gangrene, given its substantial morbidity and mortality, according to Susan J. Bersoff-Matcha, MD, and her colleagues at the FDA.
“Although the risk for [Fournier gangrene] is low, serious infection should be considered and weighed against the benefits of SGLT2 inhibitor therapy,” said Dr. Bersoff-Matcha and co-authors in their recent report published in the Annals of Internal Medicine (2019 May 6. doi: 10.7326/M19-0085).
In the previous warning, FDA officials said 12 cases of Fournier gangrene in patients taking an SGLT2 inhibitor had been reported to the agency or in medical literature from March 2013, when the first such inhibitor was approved, and May 2018.
In this latest report, a total of 55 Fournier gangrene cases had been reported in patients receiving SGLT2 inhibitors from March 2, 2013 through January 31, 2019.
The influx of reports may have been prompted by growing awareness of the safety issue, investigators said, but could also reflect the increasing prevalence of diabetes combined with SGLT2 inhibitor use. The researchers also noted that diabetes is a comorbidity in 32% to 66% of cases of Fournier gangrene.
But the likliehood that diabetes mellitus alone causes Fournier gangrene seems unlikley, given that Dr. Bersoff-Matcha and co-authors only found 19 Fournier gangrene cases associated with other classes of antiglycemic agents reported to the FDA or in the literature over a 35-year time frame.
“If Fournier gangrene were associated only with diabetes mellitus and not SGLT2 inhibitors, we would expect far more cases reported with the other antiglycemic agents, considering the 35-year timeframe and the large number of agents,” they said in their report.
Cases were reported for all FDA-approved SGLT2 inhibitors besides ertugliflozin, an agent approved for use in the U.S. in December 2017. The lack of cases reported for this drug could be related to its limited time on the market, the investigators said.
Fournier gangrene, marked by rapidly progressing necrotizing infection of the genitalia, perineum, and perianal region, requires antibiotics and immediate surgery, according to Dr. Bersoff-Matcha and colleagues.
“Serious complications and death are likely if Fournier gangrene is not recognized immediately and surgical intervention is not carried out within the first few hours of diagnosis,” they said in the report.
Of the 55 cases reported in patients receiving SGLT2 inhibitors, 39 were men and 16 were women, with an average of 9 months from the start of treatment to the event, investigators said.
At least 25 patients required multiple surgeries, including one patient who had 17 trips to the operating room, they said. A total of 8 patients had a fecal diversion procedure, and 4 patients had skin grafting.
Six patients had multiple encounters with a provider before being diagnosed, suggesting that the provider may have not recognized the infection due to its nonspecific symptoms, which include fatigue, fever, and malaise.
“Pain that seems out of proportion to findings on physical examination is a strong clinical indicator of necrotizing fasciitis and may be the most important diagnostic clue,” Dr. Bersoff-Matcha and co-authors said in their report.
The incidence of Fournier gangrene in patients taking SGLT2 inhibitors can’t be established by these cases reported to the FDA, which are spontaneously provided by health care providers and patients, investigators said.
“We suspect that our numbers underestimate the true burden,” they said in their report.
Dr. Bersoff-Matcha and co-authors disclosed no conflicts of interest related to their report.
SOURCE: Bersoff-Matcha SJ, et al. Ann Intern Med. 2019 May 6. Doi: doi:10.7326/M19-0085.
This article was updated May 9, 2019.
since the US Food and Drug Administration (FDA) issued a 2018 warning about this rare but serious infection, researchers say.
Health care providers prescribing SGLT2 inhibitors to patients with diabetes should have a high index of suspicion for the signs and symptoms of Fournier gangrene, given its substantial morbidity and mortality, according to Susan J. Bersoff-Matcha, MD, and her colleagues at the FDA.
“Although the risk for [Fournier gangrene] is low, serious infection should be considered and weighed against the benefits of SGLT2 inhibitor therapy,” said Dr. Bersoff-Matcha and co-authors in their recent report published in the Annals of Internal Medicine (2019 May 6. doi: 10.7326/M19-0085).
In the previous warning, FDA officials said 12 cases of Fournier gangrene in patients taking an SGLT2 inhibitor had been reported to the agency or in medical literature from March 2013, when the first such inhibitor was approved, and May 2018.
In this latest report, a total of 55 Fournier gangrene cases had been reported in patients receiving SGLT2 inhibitors from March 2, 2013 through January 31, 2019.
The influx of reports may have been prompted by growing awareness of the safety issue, investigators said, but could also reflect the increasing prevalence of diabetes combined with SGLT2 inhibitor use. The researchers also noted that diabetes is a comorbidity in 32% to 66% of cases of Fournier gangrene.
But the likliehood that diabetes mellitus alone causes Fournier gangrene seems unlikley, given that Dr. Bersoff-Matcha and co-authors only found 19 Fournier gangrene cases associated with other classes of antiglycemic agents reported to the FDA or in the literature over a 35-year time frame.
“If Fournier gangrene were associated only with diabetes mellitus and not SGLT2 inhibitors, we would expect far more cases reported with the other antiglycemic agents, considering the 35-year timeframe and the large number of agents,” they said in their report.
Cases were reported for all FDA-approved SGLT2 inhibitors besides ertugliflozin, an agent approved for use in the U.S. in December 2017. The lack of cases reported for this drug could be related to its limited time on the market, the investigators said.
Fournier gangrene, marked by rapidly progressing necrotizing infection of the genitalia, perineum, and perianal region, requires antibiotics and immediate surgery, according to Dr. Bersoff-Matcha and colleagues.
“Serious complications and death are likely if Fournier gangrene is not recognized immediately and surgical intervention is not carried out within the first few hours of diagnosis,” they said in the report.
Of the 55 cases reported in patients receiving SGLT2 inhibitors, 39 were men and 16 were women, with an average of 9 months from the start of treatment to the event, investigators said.
At least 25 patients required multiple surgeries, including one patient who had 17 trips to the operating room, they said. A total of 8 patients had a fecal diversion procedure, and 4 patients had skin grafting.
Six patients had multiple encounters with a provider before being diagnosed, suggesting that the provider may have not recognized the infection due to its nonspecific symptoms, which include fatigue, fever, and malaise.
“Pain that seems out of proportion to findings on physical examination is a strong clinical indicator of necrotizing fasciitis and may be the most important diagnostic clue,” Dr. Bersoff-Matcha and co-authors said in their report.
The incidence of Fournier gangrene in patients taking SGLT2 inhibitors can’t be established by these cases reported to the FDA, which are spontaneously provided by health care providers and patients, investigators said.
“We suspect that our numbers underestimate the true burden,” they said in their report.
Dr. Bersoff-Matcha and co-authors disclosed no conflicts of interest related to their report.
SOURCE: Bersoff-Matcha SJ, et al. Ann Intern Med. 2019 May 6. Doi: doi:10.7326/M19-0085.
This article was updated May 9, 2019.
FROM THE ANNALS OF INTERNAL MEDICINE
Key clinical point: The number of Fournier gangrene cases reported in patients receiving sodium-glucose cotransporter-2 (SGLT2) inhibitors has increased in the time since an FDA warning was issued about this rare but potentially serious infection.
Major finding: The previous FDA warning noted 12 reported cases from March 1, 2013 through March 1, 2018. This latest report included a total of 55 cases reported through January 31, 2019.
Study details: A review of spontaneous postmarketing cases of Fournier gangrene reported to the FDA or in the medical literature.
Disclosures: Authors disclosed no conflicts of interest related to the study.
Source: Bersoff-Matcha SJ, et al. Ann Intern Med. 2019 May 6.
Employed physicians now outnumber independent doctors
For the first time, employed physicians outnumber independent physicians, according to a survey from the American Medical Association.
The AMA’s annual Physician Practice Benchmark Survey, which queried 3,500 doctors, showed that 47% of all physicians in 2018 were employed, compared with 46% of doctors who were self-employed that year. The number of employed physicians has risen 6 percentage points since 2012, while the number of self-employed doctors has fallen by 7 percentage points over the same period, according to the study published May 6 on the AMA website.
Younger physicians and women doctors were more likely to be employed than their counterparts. Nearly 70% of physicians under age 40 years were employees in 2018, compared with 38% of physicians 55 years and older, the study found. About 35% of physicians worked either directly for a hospital or in a practice at least partly owned by a hospital in 2018, up from 29% in 2012.
More than half of physicians surveyed (54%) worked in physician-owned practices in 2018 either as an owner, employee, or contractor, a decrease from 60% in 2012. Male physicians were more likely to be practice owners than female physicians. Among female doctors, 58% were employees, compared with 34% who were practice owners, while 52% of men physicians were practice owners, compared with 42% who were employees.
Surgical subspecialists had the highest share of owners (65%) followed by obstetrician-gynecologists (54%) and internal medicine subspecialists (52%). Emergency physicians had the lowest share of owners (26%) and the highest share of independent contractors (27%). Family physicians, meanwhile, had the highest share of employed physicians (57%).
A majority of doctors still work in small practices, the analysis found. In 2018, 57% of physicians worked in practices with 10 or fewer physicians versus 61% in 2012. However, fewer physicians work in solo practice. Between 2012 and 2018 the percentage of physicians in solo practice fell from 18% in 2012 to 15% in 2018.
“Transformational change continues in the delivery of health care and physicians are responding by reevaluating their practice arrangements,” AMA President Barbara L. McAneny, MD, said in a statement. “Physicians must assess many factors and carefully determine for themselves what settings they find professionally rewarding when considering independence or employment.”
The AMA’s Physician Practice Benchmark Survey is a nationally representative survey of post-residency physicians who provide at least 20 hours of patient care per week, are not employed by the federal government, and practice in one of the 50 states or the District of Columbia. The 2018 survey was conducted in September 2018, and the final data included 3,500 physicians.
For the first time, employed physicians outnumber independent physicians, according to a survey from the American Medical Association.
The AMA’s annual Physician Practice Benchmark Survey, which queried 3,500 doctors, showed that 47% of all physicians in 2018 were employed, compared with 46% of doctors who were self-employed that year. The number of employed physicians has risen 6 percentage points since 2012, while the number of self-employed doctors has fallen by 7 percentage points over the same period, according to the study published May 6 on the AMA website.
Younger physicians and women doctors were more likely to be employed than their counterparts. Nearly 70% of physicians under age 40 years were employees in 2018, compared with 38% of physicians 55 years and older, the study found. About 35% of physicians worked either directly for a hospital or in a practice at least partly owned by a hospital in 2018, up from 29% in 2012.
More than half of physicians surveyed (54%) worked in physician-owned practices in 2018 either as an owner, employee, or contractor, a decrease from 60% in 2012. Male physicians were more likely to be practice owners than female physicians. Among female doctors, 58% were employees, compared with 34% who were practice owners, while 52% of men physicians were practice owners, compared with 42% who were employees.
Surgical subspecialists had the highest share of owners (65%) followed by obstetrician-gynecologists (54%) and internal medicine subspecialists (52%). Emergency physicians had the lowest share of owners (26%) and the highest share of independent contractors (27%). Family physicians, meanwhile, had the highest share of employed physicians (57%).
A majority of doctors still work in small practices, the analysis found. In 2018, 57% of physicians worked in practices with 10 or fewer physicians versus 61% in 2012. However, fewer physicians work in solo practice. Between 2012 and 2018 the percentage of physicians in solo practice fell from 18% in 2012 to 15% in 2018.
“Transformational change continues in the delivery of health care and physicians are responding by reevaluating their practice arrangements,” AMA President Barbara L. McAneny, MD, said in a statement. “Physicians must assess many factors and carefully determine for themselves what settings they find professionally rewarding when considering independence or employment.”
The AMA’s Physician Practice Benchmark Survey is a nationally representative survey of post-residency physicians who provide at least 20 hours of patient care per week, are not employed by the federal government, and practice in one of the 50 states or the District of Columbia. The 2018 survey was conducted in September 2018, and the final data included 3,500 physicians.
For the first time, employed physicians outnumber independent physicians, according to a survey from the American Medical Association.
The AMA’s annual Physician Practice Benchmark Survey, which queried 3,500 doctors, showed that 47% of all physicians in 2018 were employed, compared with 46% of doctors who were self-employed that year. The number of employed physicians has risen 6 percentage points since 2012, while the number of self-employed doctors has fallen by 7 percentage points over the same period, according to the study published May 6 on the AMA website.
Younger physicians and women doctors were more likely to be employed than their counterparts. Nearly 70% of physicians under age 40 years were employees in 2018, compared with 38% of physicians 55 years and older, the study found. About 35% of physicians worked either directly for a hospital or in a practice at least partly owned by a hospital in 2018, up from 29% in 2012.
More than half of physicians surveyed (54%) worked in physician-owned practices in 2018 either as an owner, employee, or contractor, a decrease from 60% in 2012. Male physicians were more likely to be practice owners than female physicians. Among female doctors, 58% were employees, compared with 34% who were practice owners, while 52% of men physicians were practice owners, compared with 42% who were employees.
Surgical subspecialists had the highest share of owners (65%) followed by obstetrician-gynecologists (54%) and internal medicine subspecialists (52%). Emergency physicians had the lowest share of owners (26%) and the highest share of independent contractors (27%). Family physicians, meanwhile, had the highest share of employed physicians (57%).
A majority of doctors still work in small practices, the analysis found. In 2018, 57% of physicians worked in practices with 10 or fewer physicians versus 61% in 2012. However, fewer physicians work in solo practice. Between 2012 and 2018 the percentage of physicians in solo practice fell from 18% in 2012 to 15% in 2018.
“Transformational change continues in the delivery of health care and physicians are responding by reevaluating their practice arrangements,” AMA President Barbara L. McAneny, MD, said in a statement. “Physicians must assess many factors and carefully determine for themselves what settings they find professionally rewarding when considering independence or employment.”
The AMA’s Physician Practice Benchmark Survey is a nationally representative survey of post-residency physicians who provide at least 20 hours of patient care per week, are not employed by the federal government, and practice in one of the 50 states or the District of Columbia. The 2018 survey was conducted in September 2018, and the final data included 3,500 physicians.
Key clinical point: More doctors are employees vs. business owners for the first time.
Major finding: Of surveyed physicians, 47% are employees versus 46% who are self-employed.
Study details: Annual survey of 3,500 physicians.
Disclosures: The survey was conducted by the American Medical Association.
Source: Kane C. Updated Data on Physician Practice Arrangements. May 6, 2019.
Simple initiative boosted proportion of residents who screen for obesity
LOS ANGELES – After a simple educational initiative was implemented, the proportion of internal medicine residents who discussed the topic of overweight and obesity with patients improved from 17% to 69%, results from a single center have demonstrated.
“Everybody knows about the obesity epidemic, but nobody’s talking about it,” Hassan Mehmood, MD, said in an interview at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “They’re not doing enough to treat obesity. The United States Preventive Services Task Force [USPSTF] recommends screening all adults over the age of 18 years for obesity.”
In an effort to determine how often internal medicine residents are discussing obesity with patients, Dr. Mehmood and colleagues retrospectively reviewed the medical charts of 301 adults with a body mass index of 30 kg/m2 or greater who were seen at Temple University/Conemaugh Memorial Medical Center in Johnstown, Pa., between May and June of 2018. They recorded the total number of problems addressed, type of visit, whether obesity was discussed, and the resources used by the residents and attendings for management.
Between July and December of 2018, residents received education through lectures and conferences on obesity screening and management tools. The educational initiative included placement of posters in the clinic about obesity, and all physicians were encouraged to schedule separate visits to discuss the topic with patients. To evaluate the effects of the initiative, the researchers collected data on 255 adults with a BMI of 30 or greater who were seen in the clinic between May and June of 2018.
The mean age of patients in the study sample was between 40 and 50 years, 61% were women, and 91% of the office visits were for follow-up. The patients’ average BMI was 38, they had an average of two comorbidities, and residents most often addressed five diagnoses. From preintervention to postintervention, the researchers observed a statistically significant improvement in the frequency with which residents addressed general health maintenance with patients (from 62% to 83%; P less than .0005) and obesity (from 17% to 69%; P less than .0005). The discussions around obesity included talking about lifestyle modification, medication management, or bariatric surgical intervention.
Before the intervention, many residents reported not being aware of the USPSTF recommendations to screen all patients aged 18 years or older for obesity. They also felt pinched for time during office visits.
“They have only 30 minutes for treatment of chronic problems, so they didn’t find time to talk about obesity,” said Dr. Mehmood, who is a third-year resident at the medical center. “If residents don’t find time for talking about obesity, they can ask patients to return for a separate visit to talk about obesity and give management options to patients. Patients should know what their BMI is so that they can discuss it with their physician.”
He acknowledged that few patients are comfortable talking about their weight, and he suggested starting the conversation by asking “How do you feel about your weight?” during office visits. “That is the best question you can ask,” he said. “[It] helps open the conversation.”
Dr Mehmood reported having no financial disclosures.
LOS ANGELES – After a simple educational initiative was implemented, the proportion of internal medicine residents who discussed the topic of overweight and obesity with patients improved from 17% to 69%, results from a single center have demonstrated.
“Everybody knows about the obesity epidemic, but nobody’s talking about it,” Hassan Mehmood, MD, said in an interview at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “They’re not doing enough to treat obesity. The United States Preventive Services Task Force [USPSTF] recommends screening all adults over the age of 18 years for obesity.”
In an effort to determine how often internal medicine residents are discussing obesity with patients, Dr. Mehmood and colleagues retrospectively reviewed the medical charts of 301 adults with a body mass index of 30 kg/m2 or greater who were seen at Temple University/Conemaugh Memorial Medical Center in Johnstown, Pa., between May and June of 2018. They recorded the total number of problems addressed, type of visit, whether obesity was discussed, and the resources used by the residents and attendings for management.
Between July and December of 2018, residents received education through lectures and conferences on obesity screening and management tools. The educational initiative included placement of posters in the clinic about obesity, and all physicians were encouraged to schedule separate visits to discuss the topic with patients. To evaluate the effects of the initiative, the researchers collected data on 255 adults with a BMI of 30 or greater who were seen in the clinic between May and June of 2018.
The mean age of patients in the study sample was between 40 and 50 years, 61% were women, and 91% of the office visits were for follow-up. The patients’ average BMI was 38, they had an average of two comorbidities, and residents most often addressed five diagnoses. From preintervention to postintervention, the researchers observed a statistically significant improvement in the frequency with which residents addressed general health maintenance with patients (from 62% to 83%; P less than .0005) and obesity (from 17% to 69%; P less than .0005). The discussions around obesity included talking about lifestyle modification, medication management, or bariatric surgical intervention.
Before the intervention, many residents reported not being aware of the USPSTF recommendations to screen all patients aged 18 years or older for obesity. They also felt pinched for time during office visits.
“They have only 30 minutes for treatment of chronic problems, so they didn’t find time to talk about obesity,” said Dr. Mehmood, who is a third-year resident at the medical center. “If residents don’t find time for talking about obesity, they can ask patients to return for a separate visit to talk about obesity and give management options to patients. Patients should know what their BMI is so that they can discuss it with their physician.”
He acknowledged that few patients are comfortable talking about their weight, and he suggested starting the conversation by asking “How do you feel about your weight?” during office visits. “That is the best question you can ask,” he said. “[It] helps open the conversation.”
Dr Mehmood reported having no financial disclosures.
LOS ANGELES – After a simple educational initiative was implemented, the proportion of internal medicine residents who discussed the topic of overweight and obesity with patients improved from 17% to 69%, results from a single center have demonstrated.
“Everybody knows about the obesity epidemic, but nobody’s talking about it,” Hassan Mehmood, MD, said in an interview at the annual scientific and clinical congress of the American Association of Clinical Endocrinologists. “They’re not doing enough to treat obesity. The United States Preventive Services Task Force [USPSTF] recommends screening all adults over the age of 18 years for obesity.”
In an effort to determine how often internal medicine residents are discussing obesity with patients, Dr. Mehmood and colleagues retrospectively reviewed the medical charts of 301 adults with a body mass index of 30 kg/m2 or greater who were seen at Temple University/Conemaugh Memorial Medical Center in Johnstown, Pa., between May and June of 2018. They recorded the total number of problems addressed, type of visit, whether obesity was discussed, and the resources used by the residents and attendings for management.
Between July and December of 2018, residents received education through lectures and conferences on obesity screening and management tools. The educational initiative included placement of posters in the clinic about obesity, and all physicians were encouraged to schedule separate visits to discuss the topic with patients. To evaluate the effects of the initiative, the researchers collected data on 255 adults with a BMI of 30 or greater who were seen in the clinic between May and June of 2018.
The mean age of patients in the study sample was between 40 and 50 years, 61% were women, and 91% of the office visits were for follow-up. The patients’ average BMI was 38, they had an average of two comorbidities, and residents most often addressed five diagnoses. From preintervention to postintervention, the researchers observed a statistically significant improvement in the frequency with which residents addressed general health maintenance with patients (from 62% to 83%; P less than .0005) and obesity (from 17% to 69%; P less than .0005). The discussions around obesity included talking about lifestyle modification, medication management, or bariatric surgical intervention.
Before the intervention, many residents reported not being aware of the USPSTF recommendations to screen all patients aged 18 years or older for obesity. They also felt pinched for time during office visits.
“They have only 30 minutes for treatment of chronic problems, so they didn’t find time to talk about obesity,” said Dr. Mehmood, who is a third-year resident at the medical center. “If residents don’t find time for talking about obesity, they can ask patients to return for a separate visit to talk about obesity and give management options to patients. Patients should know what their BMI is so that they can discuss it with their physician.”
He acknowledged that few patients are comfortable talking about their weight, and he suggested starting the conversation by asking “How do you feel about your weight?” during office visits. “That is the best question you can ask,” he said. “[It] helps open the conversation.”
Dr Mehmood reported having no financial disclosures.
REPORTING FROM AACE 2019
Key clinical point:
Major finding: From preintervention to postintervention, the researchers observed a statistically significant improvement in the frequency with which residents addressed obesity with patients (from 17% to 69%; P less than .0005).
Study details: A retrospective analysis of 301 patient visits before and 255 after implementation of an educational initiative.
Disclosures: Dr. Mehmood reported having no financial disclosures.